FDA ROCALTROL NDA 018044 Approval Package — Reviews & Approval Records

This FOIAdocs regulatory document collection brings together FDA approval records for ROCALTROL, NDA 018044. The package contains 5 FDA documents totaling 42 pages, organized by original application and supplemental submission.

Research-ready collection with the FDA documents preserved as individual PDFs and organized by regulatory submission.

What's included

• Original FDA approval records
• 5 supplemental submissions represented
• 1 FDA review document
• 4 approval letters
• FOIAdocs document index and detailed manifest

Package format: Organized ZIP collection with individual FDA PDFs grouped by regulatory submission, plus a FOIAdocs document index and manifest.

Application: NDA 018044
Product: ROCALTROL
Sponsor: ESJAY PHARMA
Documents: 5
Pages: 42
Coverage: Original approval + 5 supplemental submissions represented